Gretchen S. Dieck, PhD
Safety and Risk Management Expert
gretchen.dieck@unitedbiosource.com
Strategic Advantage: Gretchen has extensive industry expertise in all aspects of biopharmaceutical safety and risk management. This stems from registrational research through regulatory approval and commercialization. Gretchen has worked with one of the most diverse and prolific portfolios of drug development. She brings a unique combination of strategic thinking and practical experience to the development and implementation of your risk management program.
As part of the Executive Leadership of United BioSource Corporation’s Epidemiology, Registries and Risk Management Group, Dr. Gretchen Dieck consults with clients to develop and implement effective safety strategies and risk management programs that protect patients while also addressing global regulatory requirements.
After a 23 year career at Pfizer Inc., Dr. Dieck joined UBC in 2010. In her most recent role as Pfizer’s Senior Vice President, Safety & Risk Management, Dr. Dieck led the organization’s product safety functions, providing pharmacovigilance, pharmacoepidemiology, risk management, project management, and compliance functions across a broad and diverse portfolio of products. One of her notable accomplishments while at Pfizer was the conceptualization and implementation of Pfizer’s Medicine Safety website. In previous roles, she designed and implemented drug safety studies and researched new methods for post marketing surveillance studies.
Dr. Dieck provided significant input to the legislators who wrote many of the product safety requirements in the 2007 FDA Amendments Act. In addition to representing PhRMA during PDUFA III and PDUFA IV discussions, she co-led the Post Market Safety Group for PDUFA IV. Her PhRMA involvement also includes past Chair of the Pharmacovigilance and Epidemiology Technical Group and former head of the Risk Management Working Group of the Pharmaceuticals Innovation Steering Committee. Dr. Dieck was a member of the ICH Risk Communication Working Group.
Dr. Dieck received her M. Phil and PhD from Yale University where she also held a Postdoctoral Fellowship in Epidemiology. She is a member of the American College of Epidemiology, the Society for Epidemiologic Research, the International Society for Pharmacoepidemiology, and the American Public Health Association. Dr. Dieck is a Founding Member of the International Society for Pharmacoepidemiology and served as an Assistant Adjunct Professor of Public Health at Columbia University’s School of Public Health.
